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Efficacy of High-intensity Laser Therapy (HILT) in the Patients With Cervical Disc Herniation

Primary Purpose

Cervical Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High Intensity Laser Therapy
Ultrasound
Transcutaneous nerve stimulation (TENS)
Exercise
Sponsored by
Baskent University Ankara Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Disc Herniation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with cervical disc herniation diagnosed by MRI whose symptoms started for at least 3 months ago
  • Not receiving physical therapy and rehabilitation in the last 3 months
  • Not taking any medications such as analgesics, anti-inflammatoires or muscle relaxants for the treatment of symptoms.

Exclusion Criteria:

  • patients with major psychiatric disease, cervical spine surgery and rheumatological disease; pacemaker users; those who were injected with local corticosteroids; pregnant women; cancer patients

Sites / Locations

  • Baskent University Ankara Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Exercise Group

High Intensity Laser Therapy(HILT) Group

Conventional Physiotherapy Group

Arm Description

Only exercises

Exercises+HILT

Exercise+Hotpack+Transcutaneous nerve stimulation (TENS)+Ultrasound

Outcomes

Primary Outcome Measures

Neck Disability Index
This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result
Neck Disability Index
This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result
Neck Disability Index
This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result

Secondary Outcome Measures

Short Form Health Survey-36
A generic health survey which assesses health concepts that are pertinent to functional status and well-being such as physical function, bodily pain, role limitation due to emotional and physical problems. The sub scale values are reported: physical functioning, bodily pain, vitality, general health, social functioning, role limitation due to emotional problems, role limitation due to physical problems, mental health. The lowest and highest possible raw score for the subscales are as follows: physical functioning 10-30, physical role 4- 8, bodily pain 2-12, general health 5-25, vitality 4-24, social functioning 2-10, emotional role 3-6, mental health 5-30. Higher values signify better well being in all subgroups. The raw score is then used to calculate the 'transformed scale: Transformed scale= [(actual raw score- lowest possible raw score)/possible raw score range]100.
Short Form Health Survey-36
A generic health survey which assesses health concepts that are pertinent to functional status and well-being such as physical function, bodily pain, role limitation due to emotional and physical problems. The sub scale values are reported: physical functioning, bodily pain, vitality, general health, social functioning, role limitation due to emotional problems, role limitation due to physical problems, mental health. The lowest and highest possible raw score for the subscales are as follows: physical functioning 10-30, physical role 4- 8, bodily pain 2-12, general health 5-25, vitality 4-24, social functioning 2-10, emotional role 3-6, mental health 5-30. Higher values signify better well being in all subgroups. The raw score is then used to calculate the 'transformed scale: Transformed scale= [(actual raw score- lowest possible raw score)/possible raw score range]100.
Short Form Health Survey-36
A generic health survey which assesses health concepts that are pertinent to functional status and well-being such as physical function, bodily pain, role limitation due to emotional and physical problems. The sub scale values are reported: physical functioning, bodily pain, vitality, general health, social functioning, role limitation due to emotional problems, role limitation due to physical problems, mental health. The lowest and highest possible raw score for the subscales are as follows: physical functioning 10-30, physical role 4- 8, bodily pain 2-12, general health 5-25, vitality 4-24, social functioning 2-10, emotional role 3-6, mental health 5-30. Higher values signify better well being in all subgroups. The raw score is then used to calculate the 'transformed scale: Transformed scale= [(actual raw score- lowest possible raw score)/possible raw score range]100.
Visual Analog Scale
The Visual Analog Scale provides a subjective, visual linear pain score from 0 to 10 cm scored by the patient where 0 cm is no pain.
Visual Analog Scale
The Visual Analog Scale provides a subjective, visual linear pain score from 0 to 10 cm scored by the patient where 0 cm is no pain.
Visual Analog Scale
The Visual Analog Scale provides a subjective, visual linear pain score from 0 to 10 cm scored by the patient where 0 cm is no pain.

Full Information

First Posted
July 13, 2022
Last Updated
August 3, 2023
Sponsor
Baskent University Ankara Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05474625
Brief Title
Efficacy of High-intensity Laser Therapy (HILT) in the Patients With Cervical Disc Herniation
Official Title
Efficacy of High-intensity Laser Therapy (HILT) in the Patients With Cervical Disc Herniation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University Ankara Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The worldwide prevalence of neck pain is between 16.7-75.1%, it has been seen at an increasing rate in recent years due to sedentary living conditions. Pharmacological treatment, neck collar, traction, manual therapy, interventional injection techniques, surgical treatment and conventional physical therapy methods such as hotpack, ultrasound, TENS (Transcutaneous electrical nerve stimulation), vacuum interference, exercise are applied in the treatment of neck pain. In recent years, High Intensity Laser Therapy (HILT) has been used as a painless and non-invasive physical therapy agent. It received FDA approval in 2002 for HILT in the treatment of variety of musculoskeletal disorders. There are a few studies in the literature investigating the efficacy of HILT in chronic neck pain. There is only one study investigating the efficacy of HILT in cervical disc herniation. In this study, the efficacy of HILT and ultrasound-TENS in the treatment of neck pain caused by cervical disc herniation has been compared, but the results of the exercise control group and long-term follow-up were not available. The aim of this randomized controlled trial is to evaluate the short and long-term efficacy of HILT treatment using improvement in the pain, range of motion, activities of daily living and functionality of the cervical spine in patients with cervical disc herniation. In group 1, only exercises will be applied; in the group 2, HILT will be applied in addition to exercise; in the group 3, hotpack, TENS, ultrasound will be applied in addition to exercises.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Herniation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
Only exercises
Arm Title
High Intensity Laser Therapy(HILT) Group
Arm Type
Active Comparator
Arm Description
Exercises+HILT
Arm Title
Conventional Physiotherapy Group
Arm Type
Active Comparator
Arm Description
Exercise+Hotpack+Transcutaneous nerve stimulation (TENS)+Ultrasound
Intervention Type
Device
Intervention Name(s)
High Intensity Laser Therapy
Intervention Description
For each 25 cm² of painful area, 1.02 minutes of treatment will give in the analgesic phase, with an energy of 8.0 watt, a dose of 5 Joules/ cm², a frequency of 25 Hertz(Hz) and a total energy of 125 joules. The application time for one session was approximately 15 minutes. Total 15 sessions will be applied to the neck area for a period of 3 weeks, 5 days a week.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
This treatment was applied to the cervical paravertebral region with a direct contact with the skin with the aid of an ultrasonic gel, at a dose of 1 megahertz(MHz) and 1.5 Watt/cm² for 4 minutes
Intervention Type
Device
Intervention Name(s)
Transcutaneous nerve stimulation (TENS)
Intervention Description
TENS was performed using 4 adhesive electrodes 5 × 5 cm size in the cervical paravertebral region, 80 Hertz (Hz) frequency and 180 miliseconds current for 20 minutes.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
A specific program consisted of 15 minutes exercise sessions was provided under the supervision of a physiotherapist . All patients will perform isometric strengthening exercises, active range of motion exercises, and cervical region stretching exercises for 15 sessions (during 3 weeks, on weekdays).
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result
Time Frame
Pre-treatment
Title
Neck Disability Index
Description
This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result
Time Frame
1. month
Title
Neck Disability Index
Description
This scale is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring was between 0-50, where high scores indicate a poor result
Time Frame
3. month
Secondary Outcome Measure Information:
Title
Short Form Health Survey-36
Description
A generic health survey which assesses health concepts that are pertinent to functional status and well-being such as physical function, bodily pain, role limitation due to emotional and physical problems. The sub scale values are reported: physical functioning, bodily pain, vitality, general health, social functioning, role limitation due to emotional problems, role limitation due to physical problems, mental health. The lowest and highest possible raw score for the subscales are as follows: physical functioning 10-30, physical role 4- 8, bodily pain 2-12, general health 5-25, vitality 4-24, social functioning 2-10, emotional role 3-6, mental health 5-30. Higher values signify better well being in all subgroups. The raw score is then used to calculate the 'transformed scale: Transformed scale= [(actual raw score- lowest possible raw score)/possible raw score range]100.
Time Frame
pre-treatment
Title
Short Form Health Survey-36
Description
A generic health survey which assesses health concepts that are pertinent to functional status and well-being such as physical function, bodily pain, role limitation due to emotional and physical problems. The sub scale values are reported: physical functioning, bodily pain, vitality, general health, social functioning, role limitation due to emotional problems, role limitation due to physical problems, mental health. The lowest and highest possible raw score for the subscales are as follows: physical functioning 10-30, physical role 4- 8, bodily pain 2-12, general health 5-25, vitality 4-24, social functioning 2-10, emotional role 3-6, mental health 5-30. Higher values signify better well being in all subgroups. The raw score is then used to calculate the 'transformed scale: Transformed scale= [(actual raw score- lowest possible raw score)/possible raw score range]100.
Time Frame
1. months
Title
Short Form Health Survey-36
Description
A generic health survey which assesses health concepts that are pertinent to functional status and well-being such as physical function, bodily pain, role limitation due to emotional and physical problems. The sub scale values are reported: physical functioning, bodily pain, vitality, general health, social functioning, role limitation due to emotional problems, role limitation due to physical problems, mental health. The lowest and highest possible raw score for the subscales are as follows: physical functioning 10-30, physical role 4- 8, bodily pain 2-12, general health 5-25, vitality 4-24, social functioning 2-10, emotional role 3-6, mental health 5-30. Higher values signify better well being in all subgroups. The raw score is then used to calculate the 'transformed scale: Transformed scale= [(actual raw score- lowest possible raw score)/possible raw score range]100.
Time Frame
3. months
Title
Visual Analog Scale
Description
The Visual Analog Scale provides a subjective, visual linear pain score from 0 to 10 cm scored by the patient where 0 cm is no pain.
Time Frame
pre-treatment
Title
Visual Analog Scale
Description
The Visual Analog Scale provides a subjective, visual linear pain score from 0 to 10 cm scored by the patient where 0 cm is no pain.
Time Frame
1. month
Title
Visual Analog Scale
Description
The Visual Analog Scale provides a subjective, visual linear pain score from 0 to 10 cm scored by the patient where 0 cm is no pain.
Time Frame
3. month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with cervical disc herniation diagnosed by MRI whose symptoms started for at least 3 months ago Not receiving physical therapy and rehabilitation in the last 3 months Not taking any medications such as analgesics, anti-inflammatoires or muscle relaxants for the treatment of symptoms. Exclusion Criteria: patients with major psychiatric disease, cervical spine surgery and rheumatological disease; pacemaker users; those who were injected with local corticosteroids; pregnant women; cancer patients
Facility Information:
Facility Name
Baskent University Ankara Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Efficacy of High-intensity Laser Therapy (HILT) in the Patients With Cervical Disc Herniation

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